(93 days)
The intended use of this device is the bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities. The indications for use are the necessity and advisability of a clean and healthy environment in these facilities to prevent the spread of disease.
The safety and usefulness of the VÄNNA Bathing System is based on a long history of use of hydro-baths with similar characteristics. As referred to previously the VÄNNA Bathing System uses similar technology and components as other devises already on the market. Technological updates have been used in the VÄNNA Bathing System in the temperature sensor and temperature read-out indicators but these differences enhance the reliability of this devise.
This document is a 510(k) summary for the VÄNNA Bathing System, asserting its substantial equivalence to other legally marketed hydro-baths. It does not contain information about specific acceptance criteria, a study proving those criteria, or the detailed aspects of a clinical study (like sample sizes, ground truth establishment, or expert involvement) typically associated with software or AI/ML device submissions.
The 510(k) essentially states:
- Device: VÄNNA Bathing System (a hydro-bath).
- Basis for Equivalence: Long history of use of similar hydro-baths, similar technology and components to existing devices (Century Bathing System, Sanitas Bathing System, Smart Tub).
- Technological Updates: Temperature sensor and temperature read-out indicators, which enhance reliability.
- Intended Use: Bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities, to prevent the spread of disease.
Therefore, I cannot provide the requested information because the provided text does not describe a study with acceptance criteria or performance metrics for a device that uses AI/ML or requires such detailed clinical validation. The submission is focused on demonstrating substantial equivalence to predicate devices based on design and intended use, not on proving performance against specific quantitative criteria through a study.
The questions in your prompt are highly relevant for software and AI/ML medical devices that undergo rigorous performance evaluation. This document describes a physical medical device (a bathing system) where the "acceptance criteria" are implied by its functional similarity and safety record to existing, predicate devices rather than a set of measurable performance targets.
§ 890.5100 Immersion hydrobath.
(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.